The following data is part of a premarket notification filed by Velocimed Inc. with the FDA for Premere Delivery Sheath, Model Pds.
| Device ID | K043084 |
| 510k Number | K043084 |
| Device Name: | PREMERE DELIVERY SHEATH, MODEL PDS |
| Classification | Introducer, Catheter |
| Applicant | VELOCIMED INC. 6550 WEDGWOOD RD. NORTH SUITE 150 Minneapolis, MN 55311 |
| Contact | John Carline |
| Correspondent | John Carline VELOCIMED INC. 6550 WEDGWOOD RD. NORTH SUITE 150 Minneapolis, MN 55311 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-08 |
| Decision Date | 2005-05-02 |
| Summary: | summary |